ISO 9001:2008 - Implementation in practice

A

Asherlee

#1
To all,

Most (or many) of us have read and studied the changes made in ISO 9001:2008. At some stage we will need to change our company procedures, etc. in order for them to comply with the requirements of ISO 9001:2008.
I have compiled a table which, in my opinion, reflects the main changes that need to be made to the TEXT of company procedures, etc. in order to ensure compliance with ISO 9001:2008. Input from readers is welcome.

Asherlee.
 

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S

somerqc

#2
Nice table; however, I won't be making any changes to my procedures just for the 2008 standard.

Why? All/most of the changes are purely semantics and should have very little to no impact on the actual procedures.

According to my CB, the only thing I need to change is any references to ISO 9001:2000 (re: advertising and such).

My :2cents:

John
 
G

gooofii

#3
Nice table; however, I won't be making any changes to my procedures just for the 2008 standard.

Why? All/most of the changes are purely semantics and should have very little to no impact on the actual procedures.

According to my CB, the only thing I need to change is any references to ISO 9001:2000 (re: advertising and such).

My :2cents:

John
I agree with somerqc.. I don't see '' DEEP'' changes to be honest:notme:
 
A

Asherlee

#4
Thanks for the quick input.

We all agree that ISO 9001:2008 does not add any major new items for implementation IN PRACTICE; however, when a NB checks a SOP and finds that it refers to, for example, “regulatory requirements” and NOT to “statutory and regulatory requirements”, then the text of the SOP does not comply with ISO 9001:2008.

Regards,
Asherlee.
 

Colin

Quite Involved in Discussions
#5
Perhaps the problem is that your SOP's contain direct quotes from the standard. If ever anyone needed convincing not to put the words of the standard in procedures or the manual, this might do it. :)
 
A

Asherlee

#6
Hi Colpart,

Your point is a good one; however, in my opinion it is virtually impossible to avoid selective quotation or paraphrasing from the standard at some point, e.g. a list of the items (see 5.6.2 of ISO 9001) to be reviewed by Management (Man.) at the Man. Review is likely to appear in the SOP on Man. Review.

Regards,

Asherlee
 

Colin

Quite Involved in Discussions
#7
You are right that there is a temptation to quote, but it is usually better to 'translate' the requirement into your own language e.g. 5.6.2 c) 'process performance and product conformity' - who uses that terminology in normal business usage? Perhaps if we used 'how well our processes are doing and how often we get it right/wrong', more people would understand what we mean.
 
R

RickRay

#8
Asherlee,

Nice table. I had one question. Did you really mean to repeat yourself on the SOP for Internal Audits and the SOP on CAPA?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
At some stage we will need to change our company procedures, etc. in order for them to comply with the requirements of ISO 9001:2008.
I would challenge that premise.
when a NB checks a SOP and finds that it refers to, for example, “regulatory requirements” and NOT to “statutory and regulatory requirements”, then the text of the SOP does not comply with ISO 9001:2008.
Now, let's talk about something that is substantive. In your organization, what NEW legal (statutory) product requirements will you have to identify and comply with? Can you offer any example that applies to your organization?

I contend that for most organizations that were doing their job, the return of the word statutory to ISO 9001 is irrelevant, because they were already identifying all legal product requirements they were subjected to.
 
A

Asherlee

#10
Hi Rickray,

I included the reference to CAPA under both the SOP for "Internal Audit" and the SOP for CAPA, as some people refer to CAPA's in both these procedures -take your pick. One of the results of an internal audit may be to initiate a CAPA.

Regards,

Asherlee
 
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